FDA Inspection 1280476 — Pharma Works LLC
The FDA completed an inspection of Pharma Works LLC on August 29, 2025 in Milwaukee, WI. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 9 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 29, 2025
- Fiscal Year
- 2025
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Milwaukee, WI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 22813 | 21 CFR 111.553 | Written procedures - establish; product complaint |
| 22843 | 21 CFR 111.70(b) | Specifications - components |
| 22847 | 21 CFR 111.70(e) | Specifications - finished dietary supplement |
| 22858 | 21 CFR 111.95(b) | Records - make and keep |
| 22859 | 21 CFR 111.103 | Written procedures - establish; quality control operations |
| 22867 | 21 CFR 111.140(b)(1) | Quality control operations; written procedures; material review, disposition |
| 22884 | 21 CFR 111.205(a) | Master manufacturing record - prepared |
| 22908 | 21 CFR 111.503 | Written procedures - establish; returned dietary supplements |